Clinical Trial: Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

Brief Summary: The primary objective of this study is to determine the overall response rate to erlotinib in patients with polycythemia vera (PV). Response rate will be assessed by improvement in the complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in this study to explore a possible molecular targeting of the driving mechanism of PV.

Detailed Summary: This is a phase II open-label study. Patients will be screened for MPN diagnoses and patients with Polycythemia vera proven to have JAK2V617F mutation will be given the option to enroll. Consenting patients will take erlotinib daily for 16 weeks. Blood work and pharmacokinetics will be drawn for serum level monitoring. Doses will be administered according to side effects or held. First assessment will be at day 15 wth subsequent assessments at 28 day intervals. Non-responders will be taken off the study and managed according to standard of care. Patients who do respond will continue taking the therapy for a total of 12 months. Observation will be for a total of 12 months after finishing treatment. In addition to the clinical aspect of this study, there will be correlative studies where molecular response will be checked and its correlation with clinical response.
Sponsor: University of Oklahoma

Current Primary Outcome: Overall response rate to include Complete Hematological response, Complete molecular response, partial hematological response, and minimal hematological response [ Time Frame: First assessment will be at day 15 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Toxicity, improvement in splenomegaly size, and a decrease of mutant JAK2V617F allele burden, measured by PCR [ Time Frame: First assessment at day 15, subsequent assessments at 28 day intervals ]

Original Secondary Outcome: Same as current

Information By: University of Oklahoma

Dates:
Date Received: December 22, 2009
Date Started: December 2009
Date Completion:
Last Updated: May 19, 2014
Last Verified: May 2014